Patient Educational Video to Enhance Patient Decision Satisfaction for the Treatment of Pelvic Organ Prolapse
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pelvic Organ Prolapse
- Sponsor
- Ohio State University
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Difference in SDS-PFD score
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a single-blinded, randomized controlled trial investigating if a patient educational video on pelvic organ prolapse improves patient understanding of this pelvic floor disorder and satisfaction in their healthcare decision making for its management.
Detailed Description
This is a randomized controlled trial. Participants will be randomized either to watch a pre-visit educational video on pelvic organ prolapse (POP) in addition to routine physician counseling (intervention group) or routine physician counseling alone (control group). The counseling physician will be blinded. All participants will complete a pre-visit survey that includes the Prolapse and Incontinence Knowledge - POP (PIKQ-POP) and a demographics questionnaire. The PIKQ-POP has been validated to assess for patient knowledge of POP. Those randomized to the intervention group will take a brief survey after watching the video asking if they had any technical issues with the video and confirming they watched the video. At the end of all initial clinic visits, participants will complete a post-visit survey that includes the validated Satisfaction with Decision Scale for Pelvic Floor Disorders (SDS-PFD) to assess the primary outcome of change in patient decision satisfaction. The SDS is designed to assess satisfaction with a treatment decision. The SDS was modified into the SDS-PFD to be specific for women making decisions regarding surgical treatment for pelvic floor disorders. To assess the secondary outcomes of change in decision conflict and POP knowledge, the post-visit survey will also include a validated Decision Conflict Scale (DCS) and the PIKQ-POP. The DCS was developed to evaluate the effect of health care decision aids and decision-supporting interventions on decision uncertainty. The physician will also complete a counseling survey at the end of the visit to assess their perception of patient comprehension and their ease of counseling. After undergoing their chosen management option, participants will also complete a post-management survey in follow up which will include the SDS-PFD and PIKQ-POP.
Investigators
Lisa Hickman
Assistant Professor
Ohio State University
Eligibility Criteria
Inclusion Criteria
- •Initial evaluation for symptomatic POP
- •Age greater than or equal to 18 years old
- •Reliable access to text or e-mail
Exclusion Criteria
- •Pregnant women
- •Presence of cognitive disability
- •Non-English speaking patient or requiring interpreter assistance
- •Women with a history of prior pelvic organ prolapse therapy, i.e. pelvic floor physical therapy, pessary, or surgical repair
Outcomes
Primary Outcomes
Difference in SDS-PFD score
Time Frame: Within 1 day of completion of the initial visit
The difference in the score of a validated decision satisfaction questionnaire, the Satisfaction with Decision Scale for Pelvic Floor Disorders (SDS-PFD), will be compared between the two arms. A difference of 0.4 will be considered clinically meaningful. The SDS-PFD was modified from the original SDS to be specific for women making decisions regarding surgical treatment for PFD. It has 6 questions with a 5-point response scale. The score is calculated by taking the mean of the 6 answers (1-5). Higher scores correspond with higher satisfaction.
Secondary Outcomes
- Patient perception of their knowledge(Within 1 day of completion of the initial visit)
- Physician's perception of patient's understanding of prolapse(Within 1 day of completion of the initial visit)
- Difference in PIKQ-POP scores after management of prolapse(Within 2 weeks to 1 year after undergoing the chosen management option)
- Difference in PIKQ-POP score(Within 1 day of completion of the initial visit)
- Difference in DCS score(Within 1 day of completion of the initial visit)
- Difference in SDS-PFD scores after management of prolapse(Within 2 weeks to 1 year after undergoing the chosen management option)